Received Feb 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
max/low temperature reached: negative 4.5 °c for IPOL for the duration: fourteen hours, with no reported adverse event; Initial information received on 18-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered with IPV (VERO) [IPOL] where max/low temperature reached: negative 4.5 °c for the duration: fourteen hours, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the an unknown dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization was exposed to a max/low temperature that reached: negative 4.5 °c for the duration: fourteen hours, with no reported adverse event (poor quality product administered) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly-There was no previous excursion; human error was not involved; the product was administered; extended stability does not cover the data of excursion; Vaccines were put in the backup refrigerator, but the equipment was not able to adjust the temperature needed. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.